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Restoring Sinus Rhythm Using Dual-Shock Technique in Patients With Atrial Fibrillation

NCT07560644 · Status: NOT_YET_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 177

Last updated 2026-05-07

No results posted yet for this study

Summary

The goal of this clinical trial is to assess the efficacy and acute safety of the dual electrical cardioversion (ECV) technique compared with the conventional ECV in patients with persistent atrial fibrillation. The main question it aims to answer are:

* Is dual ECV more effective than conventional ECV to achieve sinus rhythm restoration?
* Is dual ECV safe compared with conventional ECV?
* Which are the main factors associated with cardioversion success?

Researchers will compare a dual ECV technique with 400J with dual ECV with 200J and conventional ECV.

Participants will be randomized to one ECV configuration. The primary efficacy endpoint will be considered the percentage of patients with successful cardioversion with the first shock. The coprimary safety endpoint will be the occurrence of adverse events during ECV.

Conditions

Interventions

PROCEDURE

Conventional Electrical Cardioversion

Defibrillation pads will be placed in the anteroposterior or anterolateral position. An initial biphasic shock of 200 J will be delivered. If sinus rhythm is not restored, a second dual shock of 400 J (crossover) will be administered. The procedures will be performed in the designated area for such procedures at each center, under deep sedation in accordance with each center's standard protocols. The choice of medication used for sedation will be at the investigator's discretion. All shocks will be delivered using biphasic energy and ECG-synchronized.

PROCEDURE

Dual-shock Electrical Cardioversion

Two pairs of defibrillation pads connected to two different defibrillators will be used. One pair of pads will be placed in the anterolateral position and the second pair in the anteroposterior position. Both defibrillators will be programmed to deliver a biphasic shock of 100 J each (200 J group) or 200 J each (400 J group) simultaneously. The maximum number of CVE attempts per patient will be 3. The procedures will be performed in the designated area for such procedures at each center, under deep sedation in accordance with each center's standard protocols. The choice of medication used for sedation will be at the investigator's discretion. All shocks will be delivered using biphasic energy and synchronized with the QRS complex.

Sponsors & Collaborators

  • Martín Negreira Caamaño

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-01
Primary Completion
2027-12-31
Completion
2028-02-27

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07560644 on ClinicalTrials.gov